Drugs

FDA Seeks Solutions to Data Barriers in Real-World Evidence Submissions

CDER and CBER are seeking industry input on how to overcome legal, privacy and technical barriers that prevent them from accessing patient-level data used to support product applications containing real-world evidence (RWE).

In a request for information (RFI) scheduled for publication in the 11/12 Federal Register, FDA said increasing use of real-world data (RWD) in regulatory submissions has exposed persistent difficulties in obtaining the underlying records needed to independently verify study findings. These challenges relate to data ownership, privacy requirements (including HIPAA and GDPR), and data-use agreements, it says.

CDER and CBER’s RFI is seeking input on:

Challenges with patient-level data submissions
Potential solutions for data-use agreements that enable more efficient RWD sharing with FDA
Solutions which allow FDA to receive, review, and retain patient level data from external parties
How FDA might collaborate with external partners to address the challenges

The input and comments are intended to inform FDA's strategic planning, policy development, and IT modernization efforts related to RWD/RWE, the agency says.

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Newer Approach Could Help Biosimilar Development: FDA

Ex-HHS Aide Says Overton Pressured Makary Over Vaccine Approval

Novocure Gets Rejection Letter on Lung Cancer Device

FDA Posts 18 Form 483 Inspection Records